Patent Application
20060076251
Not Applicable
Not Applicable
Not Applicable
1. Field of the Invention
The present invention relates to mixing bag for packaging, storing and shipping (using a separate shipping container) a dry material to be mixed in the mixing bag and more particularly relates to a preformed mixing bag adapted to store a dry powder which is to be mixed with a process compatible solution to form a suspension of powder in the solution having the material in suspension with a selected concentration which may be at least one of a high concentration capable of being diluted to a target concentration or at a target concentration intended for use without being diluted.
2. Description of the Prior Art
The use of mixing bags for storing a dry powder to be mixed in the mixing bag with a liquid is known in the art. The following prior art discloses typical mixing bags, apparatus and method for using such mixing bags.
U.S. Pat. No. 5,616,305 discloses a bag containing a selected quantity of dry powdered material wherein the volume of the bag is sufficient to add a liquid of a known maximum volume resulting in a solution in the form of a powdered salt concentrate wherein the solution is mixed by use of a pump connected to a water supply line. The powdered salt partially dissolves when the bag is completely filled with water.
U.S. Pat. No. 5,643,585 discloses a non-soluble particulate coloring material comprising dry ground red micro algae-derived material as a base color material. The non-soluble particulate matter was stored in a transparent plastic bag for testing as opposed to mixing with a fluid.
U.S. Pat. Nos. 6,149,294; 5,511,875 and 5,348,389 each disclose a system for mixing a powder and a fluid to produce a slurry. The system has a bag for mixing the powder and fluid therein and discloses use of a pump that recirculates and mixes the contents of the bag.
U.S. Pat. No. 5,362,642 discloses a cell culture media containment system having a mixing bag substantially enclosed within a storage bag powdered cell culture media and other constituents are introduced into the mixing bag and are mixed therein. Therefore, the reconstituted media is conveyed from the mixing bag into the storage bag. The mixing bag has an access port in the top to assist in the introduction of constituents into the mixing chamber and an introduction plate in the top having an opening allowing for insertion of tubes there through into the mixing chamber. The storage bag has an introduction plats having an opening for possessing tubing into the storage bag and to support a discharge tube.
U.S. Pat. No. 5,121,857 discloses a system for agitating and dispensing a mixture from a bag-in-box arrangement wherein the bag-in-box has a connector having an inlet port, an outlet port and a pump.
U.S. Pat. No. 5,709,467 discloses a bag or a pouch for mixing and dispensing an alginate and water composition and wherein the pouch or bag as a sealable opening.
U.S. Pat. No. 6,298,984 discloses a package containing a medium that must be combined with an activator and mixed before the medium can be used by an end user.
U.S. Pat. No. 4,948,013 discloses a method of mixing a powder and a fluid wherein a filter is used to allow only predetermined particles to be dispensed.
U.S. Pat. Nos. 5,069,370 and 4,821,923 each disclose mixing and dispensing containers.
U.S. Design Pat. No. DES 413,258 discloses a flexible bag in the form of a dunnage bag having a valve, the dunnage bag apparently being used for personal storage of fluids or personal belongings.
U.S. Design Pat. No. DES 308,164 discloses a flexible container having an extended pouring spout for storing and dispensing fluids.
U.S. Design Pat. No. DES 304,546 discloses a flexible container having an opening which appears to be used for a filling the container with a fluid causing expansion of a bottom seam to accommodate a pre-determined volume fluid and wherein the opening is used to dispense the fluid.
European Patent Office EPO Publication Number 0 152 283 discloses apparatus for dispensing a beverage from a reservoir wherein the reservoir containing the fluid is releasably connected to the apparatus wherein a pump continuously circulates the beverage around a fluid circuit. One or more dispensing valves or taps are located in the fluid circuit from which the beverage is to be dispensed. A metering pump is provided to effect mixing of the beverage within the reservoir when the beverage is to be formed of two or more liquids.
European Patent Office EPO Publication Number 0 354 685 discloses a system for agitating and dispensing a fluid in a bag-in-box arrangement and appears to be a foreign equivalent of U.S. Pat. No. 5,121,857 discussed above.
Discloses a system for preparation and use of dialyses solution U.S. Pat. No. 5,385,564. Having a bag which is constructed to hold granulated or powder concentrate. The bag has a V-shaped bottom with an access port in the bottom. Water is flowed through the access port and into the bag using water control means having a pump. The incoming water lifts and suspends the granules or powder. The filling of the bag is monitored by trip switches operatively attached to support the weight of the bag and contents. When the bag is filled sufficiently with water, the weight of the bag and contents trips the trip switches and a signal is sent to deactivate the pumps through control circuits.
None of the known prior art anticipates, discloses, suggests or teaches a mixing bag having an interior mixing chamber having a volume sufficient to receive a predetermined weight of dry powder and a selected volume of process compatible solution to form a solution having powder in suspension with a selected concentration and at least two sealable openings wherein one of the at least two sealable openings is configured for at least one of enabling transporting dry powder into the interior mixing chamber, enabling agitation of the powder and process compatible solution in the interior mixing chamber to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentrated from the interior mixing chamber and the other of the at least two opening is configured for at least one of injecting a process compatible solution into the interior mixing chamber to form a solution having powder in suspension, enabling agitation of the powder and process compatible solution in the interior mixing chamber to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentrated from the interior mixing chamber.
Further, the system for preparation and use of dialyses solution disclosed in U.S. Pat. No. 5,385,564 does not anticipate, disclose, suggest or teach a mixing bag comprising an interior mixing chamber having a volume sufficient to receive a predetermined weight of dry material capable of being forming and remaining in suspension in a liquid and a selected volume of process compatible solution to form a solution having the material in suspension with a selected concentration.
The present invention discloses and teaches a new, novel and unique mixing bag for mixing a dry powder with a process compatible solution in a preformed mixing bag to form a suspension of powder in the process compatible solution having the material in suspension with a selected concentration which is at least one of a high concentration capable of being diluted to a target concentration and a target concentration or, in the alternative, a selected density or a density within or acceptable range of densities. The mixing bag, which in the preferred embodiment is a preformed mixing bag, comprises an interior mixing chamber having a volume sufficient to receive a predetermined weight of dry powder and a selected volume of process compatible solution to form a solution having powder in suspension with a selected concentration, e.g. g/L or selected density e.g. g/L3. The interior mixing chamber has a first end and a second end wherein the second end is located in an opposed spaced relationship to the first end. The mixing bag includes at least two sealable openings wherein one of the at least two sealable openings extends from a location exterior to the mixing bag and into communication with the interior mixing chamber at the first end and which is configured for at least one of enabling transporting dry powder into the interior mixing chamber, enabling agitation of the powder and process compatible solution in the interior mixing chamber to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentrated from the interior mixing chamber. The other of the at least two opening extends from a location exterior to the mixing bag and into communication with the interior mixing chamber at the second end and is configured for at least one of injecting the process compatible solution into the interior mixing chamber to form a solution having powder in suspension, enabling agitation of the powder and process compatible solution in the interior mixing chamber to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber. The selected concentration is at least one of a high concentration capable of being diluted to a target concentration and a target concentration.
In addition, this invention relates to a method for filling a mixing bag having the above described structure with a dry material, e.g. dry powder, such as for example a Celpure® media or e.g. a slightly hydrated media such as for example an LRA® media.
In addition, this invention relates to apparatus for mixing a dry powder with a process compatible solution in a preformed mixing bag having the above-described structure to form a suspension of powder in the process compatible solution having a selected concentration or selected density.
In an alternative embodiment, the concentration may be at a high concentration of Celpure® media or LRA® media, e.g. 100 g/L, to minimize the size of the system and the resulting solution may then be diluted with an inline mixer to achieve a lower target concentration, e.g. 2 g/L.
In addition, this invention relates to a system for mixing a dry powder with a process compatible solution in a preformed mixing bag having the above-described structure to form a suspension of powder in the solution having the material in suspension with a selected concentration or selected density.
Therefore, it is an advantage of the present invention to provide mixing bag having a volume sufficient to receive a predetermined weight of dry material capable of being forming and remaining in suspension in a process compatible solution and a selected volume of process compatible solution to form a solution having the material in suspension with a selected concentration or selected solution density.
Another advantage of the present invention is that the mixing bag can be used in methods, apparatus and a system for forming a solution having the material in suspension with a selected concentration which is at least one of a high concentration capable of being diluted to a target concentration and a target concentration intended for use without being diluted.
Another advantage of the present invention is that the selected concentration of the solution may be a high concentration to minimize system size and the resulting solution may then be diluted to achieve a lower target concentration.
Another advantage of the present invention is that a mixing bag can be a preformed mixing bag having a selected shape.
Another advantage of the present invention is that the a mixing bag has an interior mixing chamber having a first and second end located in an opposed spaced relationship to each other and include at least two sealable openings wherein one of said at least two sealable openings is configured for at least one of enabling transporting dry material into the interior mixing chamber, enabling agitation of the material and process compatible solution in the interior mixing chamber to form a solution having the material in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber and the other of said at least two openings is configured for at least one of injecting liquid into the interior mixing chamber to form a solution having the material in suspension, enabling agitation of the material and process compatible solution in the interior mixing chamber to form a solution having material in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber.
Another advantage of the present invention is that the mixing bag may have one of the at least two sealable openings configured to be sealed upon completion of transporting dry material into the interior mixing chamber and to be unsealed for at least one of enabling agitation of the material and process compatible solution to form a solution having the material in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentrated from the interior mixing chamber.
Another advantage of the present invention is that the mixing bag can be have a volume sufficient to receive a predetermined weight of dry material capable of being forming and remaining in suspension in a process compatible solution and a selected volume of a process compatible solution to form a solution having the material in suspension with a selected concentration.
Another advantage of the present invention is that the mixing bag can be have a volume sufficient to receive a predetermined weight of non-soluble powder capable of being forming and remaining in suspension in a process compatible solution and a selected volume of process compatible solution to form a solution having the material in suspension with a selected concentration. In the preferred embodiment, the non-soluble powder is diatomaceous earth. In alternative applications, the non-soluble powder may comprise Celpure® media, LRA® media or sorbents.
Another advantage of the present invention is that the mixing bag has an outer member having a predetermined shape and a sidewall defining an interior mixing chamber having a volume sufficient to receive a predetermined weight of dry powder and a selected volume of process compatible solution to form a solution.
Another advantage of the present invention is that the mixing bag has an outer member which is in the shape of an elongated thin walled rectangular member having a hollowed-out passageway defining the interior mixing chamber.
Another advantage of the present invention is that the mixing bag has an outer member which is in the shape of an elongated thin walled cylindrical member having a hollowed-out passageway defining the interior mixing chamber.
Another advantage of the present invention is that the mixing bag has an outer member which is in the shape of an elongated thin walled cylindrical member having a hollowed-out passageway defining the interior mixing chamber wherein the interior mixing chamber includes an internal conical shaped hopper for receiving dry powder.
Another advantage of the present invention is that the mixing bag at least two sealable openings may comprises a first sealable opening which is configured for enabling transporting dry powder into the interior mixing chamber; a second sealable which is configured for at least one of enabling injection of process compatible solution into the interior mixing chamber to form a solution having the powder in suspension, enabling agitation of the powder and process compatible solution in the interior mixing chamber to form a solution having the powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber; and a third sealable opening which is configured for enabling at least one of agitation of the powder and process compatible solution in the interior mixing chamber to form a solution having the powder in suspension with a selected concentration.
Another advantage of the present invention is that the mixing bag can be used in a method for filling a mixing bag with a dry powder comprising the steps of forming a mixing bag a volume sufficient to receive a predetermined weight of dry powder and a selected volume of process compatible solution to form a solution having powder in suspension with a selected concentration and at least two sealable openings one wherein one of the at least two sealable openings is configured for at least enabling transporting the dry powder from a dry powder source into the interior mixing chamber through the at least one sealable opening into the interior mixing chamber until a predetermined weight of dry powder is received with the interior mixing chamber of the mixing bag.
Another advantage of the present invention is the mixing bag having an interior mixing chamber having a predetermined weight of dry powder can be in a method for forming a solution comprising the steps of injecting a selected volume of process compatible solution, e.g. water of feedstock solution, into a mixing bag through a designated sealable opening; agitating through the at least two sealable openings the powder and process compatible solution in the interior mixing chamber to form a solution having powder in suspension with a selected concentration and withdrawing from the interior mixing chamber through the other of said at least two sealable openings the solution with a selected concentration. The selected concentration is at least one of a high concentration capable of being diluted to a target concentration and a target concentration intended for use without being diluted.
Thc present invention will become more fully understood from the following detailed description of a preferred but non-limiting embodiment thereof, described in connection with the accompanying drawings, wherein:
Before proceeding with the description of the preferred embodiment, the following background will be helpful in understanding this invention.
Dynamic depth filtration, also known as pressure precoat filtration, is a constant flow, solid-liquid separation technique that has been practiced for over 75 years. Dynamic depth filtration uses a primary filter media that is a high purity, high-performance diatomite filter aid. Diatomite is a silica powder composed of diatoms, which are rigid, porous and irregular in shape, and Diatomite is essentially a dense, chert-like, consolidated diatomaceous earth.
Diatomaceous earth is well known in the art and is made of opaline shells of diatoms and has a consistency of dry powder. Diatomaceous earth has a wide variety of uses including, without limitation, uses as a filter aid, paint additive, sorbent, abrasive and thermal insulator. Diatomaceous earth is also known as kieselguhr and tripolite.
The use of the term “diatomaceous earth” as used herein is intended to cover all of the above-described materials.
In the field of filtration, many methods of particle separation from fluids employ diatomite products as filter aids. The intricate and porous structure unique to diatomite silica is particularly effective for the physical entrapment of particles in filtration processes. It is common practice to employ diatomite products when improving he clarity of fluids that contain suspended particles or particulate matter, or have turbidity.
Diatomire products are often applied to a septum to improve clarity and increase flow rate in filtration processes, in a step sometimes referred to as “precoating.” Diatomite is also often added directly to a fluid as it is being filtered to reduce the loading or plugging of undesirable particulate at the septum while maintaining a designed liquid flow rate, in a step often referred to as “body feeding.” Depending on the particular separation involved, diatomite products may be used in precoating, body feeding, or both. The principles involved with diatomite filtration have been reviewed (Kiefer, 1991).
In some filtration applications, different diatomite products are blended together to further modify or optimize the filtration process. Also, diatomite products are sometimes combined with other substances. In some cases, these combinations may involve simple mixtures, for example, with cellulose, activated charcoal, clay, or other materials. In other cases, these combinations are composites in which diatomite products are intimately compounded with other ingredients to make sheets, pads, or cartridges. Still more elaborate modifications of any of these diatomite products are used for filtration or separation, involving, for example, surface treatment and the addition of chemicals to diatomite products, mixtures, or their composites.
In certain circumstances, diatomite products may also exhibit unique absorptive properties during filtration that can greatly enhance clarification or purification of a fluid. These adsorptive properties are highly specific, and depend upon weak forces for attraction of the absorbed species to weak electrical charges at the surface of diatomite, or upon the reactivity of silanol (i.e., ═Si—OH) functional groups that often occur at the diatomite surface. For example, an ionized silanol group (i.e., ═Si—O−) may react with a hydroniumion (i.e., H,O+) contributed by an acidic substance in solution, for example, citric acid (i.e. C6H8O7), adsorbing the donated H+ at the surface in the process.
In filtration applications, diatomic products are usually processed to provide a range of filtration rates that are closely related to their permeability reported in units of Darcies. Diatomic filter aids are available in a wide range of permeabilities. The selection of a filter aid with a particular permeability suitable for a specific process depends on the flow rate and degree of fluid clarification desired for the particular application.
Darcy's Law is well known to persons skilled in the art and is essentially an empirical law that governs flow through porous media and describes the relationship among flow rate, pressure drop and resistance. Functional filtration rates products are usually processed to provide a range of filtration rates that are closely related to their permeability as reported in units of Darcies.
One Darcy corresponds to the permeability through a filter media 1 cm thick which allows 1 cm3 of fluid with a viscosity of 1 centipoise to pass through an area of 1 cm2 in 1 second under a pressure differential of 1 atmosphere.
Dynamic depth filtering is used in the beverage and food manufacturing industries, e.g., as a filter for beer, and in the medical industry, e.g., as a filter aid for human serum filtration.
One example is a pressure filter system used in the Current Good Manufacturing Practices of the FDA (“CGMP”) production of biopharmaceutical and other high purity products. In this CGMP production, a Celpure® media is used for solid-liquid separation in a pressure filtration system. Celpure® media is available in a wide range of permeabilities. The following Table A sets forth data for certain of the commercially available Celpure® media:
Note
(1)Data is provided for comparison purposes only. Depending on compressibility, of the solids, the values may range by more than an order of magnitude. Macroscopically, Celpure ® filter aids are characterized by their powdered form dry density (0.10 g/cm3-0.40 g/cm3) and light colors that range from white to pink to gray. The maximum wet density specifications for Celpure ® media grade is about 0.3 g/cm3.
A description of the solid-liquid separation with dynamic depth filtration is set forth in a Technical Bulletin entitled Bench Scale Proof-of Principle with Celpure® Media, Technical Note AMC06, a publication of Advanced Minerals Corporation and World Minerals, Inc., Santa Barbara, Calif.
Typically, the suppliers of Diatomite comprising diatomaceous earth ship the material in bulk to an end user. The end user then mixes a predetermined volume of diatomaceous earth with a selected volume of process compatible solution, e.g. make-up water or feedstock solution, to form a solution comprising diatomaceous earth in suspension with a selected concentration, or selected solution density or when the solution density is within a density range of acceptable solution densities. The selected solution density and density range of the solution and batch mixing specifications are determined by the requirements of the end user.
The solution is then fabricated into or used as a diatomite filter media.
Typically, the batch mixing is performed by an end user customer using a large batch mixing apparatus. A typical batch mixing process will use about one (1) ton by weight of diatomaceous earth. The diatomaceous earth is transported into or loaded into a large batch mixing apparatus mixing vessel. A selected volume of a process compatible solution, e.g., make-up water, is then added to the diatomaceous earth. The ratio of process compatible solution to diatomaceous earth is dictated by the desired final selected concentration or density.
In this process, water from the local municipal water supply (which may or may not be filtered or preprocessed) is used as the process compatible solution. The large batch mixing apparatus then agitates the solution using mixing impellers or mixing blades for an appropriate mixing time, until the solution reaches the desired or selected concentration, density or a density in the density range. In this process, the selected concentration can be in the range of about 0.1 g/L to about 100 g/L.
The solution is then used to mold or fabricate the desired filter media for use as a filter.
The present invention has utility for improved handling of dry powder for forming solutions having dry powder in suspension with a selected concentration, generally, and specifically, for handling of diatomaceous earth for forming solutions having diatomaceous earth in suspension within a selected concentration wherein the selected concentration is at least one of a high concentration capable of being diluted to a target concentration and a target concentration intended for use without being diluted.
The solution can then be fabricated into a filter media that is an inert, high purity, high-performance diatomite filter as described above.
The teachings of the present invention reside in the use of a new, novel and unique mixing bag as shown in
The end user may select the selected concentration to be a high concentration, e.g. a solution of Celpure® media or LRA® media at a concentration of 100 g/L to minimize the size of the processing system, and the resulting solution may then be diluted with an inline mixer to achieve a lower target concentration, e.g. 2 g/L.
Alternatively, the solution density may be used in lieu of concentration and a selected solution density in a range of solution densities acceptable to or specified by the end user. Typically, solution densities for the selected concentration solutions in the range of about 2 g/L to about 100 g/L are in a range of about 0.5 g/cm3 to about 3 g/cm3, respectively.
The interior mixing chamber 32 has a first end 36 and a second end 38 wherein the second end 38 is located in an opposed spaced relationship to the first end 36.
The mixing bag 30 in the preferred embodiment is a preformed mixing bag having a selected shaped. In the preferred embodiment as shown
As shown in
Opening 52, the other of the at least two openings, extends from a location exterior to the mixing bag 30 and into communication with the interior mixing chamber 32 at the second end 38. Opening 52 is configured for at least one of injecting process compatible solution from the bottom section 44 into the interior mixing chamber 32 to form a solution having powder in suspension, enabling agitation of the powder and process compatible solution in the interior mixing chamber 32 to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber 32.
Also as illustrated in
As such, the preformed mixing bag 30 may include three sealable openings which comprise and include the at least two sealable openings. The three sealable openings include sealable openings 50, 52 and 54 as shown on
The first sealable opening 50 extends from a location exterior to the mixing bag 30 and into communication with the interior mixing chamber 32 at the first end 36 of the top section 42. The first sealable opening 50 may be configured for at least one of enabling transporting dry powder into the interior mixing chamber 32, enabling agitation of the powder and process compatible solution to be transported into the interior mixing chamber 32 to form a solution having powder in suspension with a selected concentration, and enabling withdrawal of the solution at a selected concentration from the interior mixing chamber 32.
In this embodiment, the mixing bag 30 includes a third sealable opening 54 which is configured specifically for enabling transporting dry powder into the interior mixing chamber 32. In this embodiment, the first sealed opening 50 is used for at least one of enabling agitation of the material and process compatible solution in the interior mixing chamber 32 to form a solution having the material in suspension with a selected concentration and enabling withdrawal of the solution at a selected concentration from the interior mixing chamber 32.
The second sealable opening 52 extends from a location exterior to the mixing bag 30 and into communication with the interior mixing chamber 32 at the second end 38 located in the bottom section 44. Opening 52 is configured for at least one of injecting process compatible solution into the interior mixing chamber 32 to form a solution having powder in suspension, enabling agitation of the powder and process compatible solution in the interior mixing chamber 32 to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber 32.
The third sealable opening 54 extends from a location exterior to the mixing bag 30 and into communication with the interior mixing chamber 32 at the first end 36 in top section 42. Opening 54 is configured for enabling transporting dry powder into the interior mixing chamber 32. In the preferred embodiment, the structure of the sealable opening 54 includes a sanitary port assembly which is discussed in greater detail in the discussions of
In addition, the embodiment of
In the mixing bag 30 having the minimum of at least two sealable openings, sealable opening 50, which is the one of the at least two sealable openings, is configured to be sealed upon completion of transporting dry powder into the interior mixing chamber and is to be unsealed for enabling agitation of a powder and process compatible solution to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution at said selected concentration from the interior mixing chamber 32.
In the mixing bag 30 having the minimum of at least two sealable openings, sealable opening 52, which is the other of the at least two sealable openings, is configured to be sealed at least one of before commencement of transporting dry powder into the interior mixing chamber and after completion of transporting dry powder into the interior mixing chamber 32. Opening 52 is to be unsealed for at least one of enabling injection of a process compatible solution into the interior mixing chamber 32 to form a solution having powder in suspension, enabling agitation of a powder and process compatible solution to form a solution having powder in suspension with a selected concentration and withdrawal of solution from the interior mixing chamber with a selected concentration.
In the perspective pictorial representation of
It is preferred that the preformed mixing bag 30 be placed into a shipping container 70 prior to the step of transporting dry powder 68 from a dry powder source through the at least one sealable opening 50, or in the alternative opening 54, into the interior mixing chamber 32 such that the mixing bag 30 has the dry powder 68 transported into the interior mixing chamber 32 when the mixing bag 30 is located within the shipping container 70.
Alternatively, the preformed mixing bag 30 can be placed into a shipping container 70 subsequent to the step of transporting dry powder 68 from a dry powder source through the at least one sealable opening 50, or in the alternative opening 54, into the interior mixing chamber 32 such that the mixing bag 30 has the dry powder 68 in the interior mixing chamber 32 when the mixing bag is placed within the shipping container 70.
In the embodiment of the mixing bag illustrated in
In the pictorial representation of
If the third sealable opening 54 is eliminated, then the first sealable opening 50 is used for filling of the mixing bag 30 with a predetermined weight of dry material, for agitation of the solution and enabling withdrawal of the solution at a selected concentration from the interior mixing chamber 32.
In both embodiments, the second sealable opening 52 is used for injecting a process compatible solution into the interior mixing chamber 32 to form a solution having powder in suspension, enabling agitation of the powder and process compatible solution in the interior mixing chamber 32 to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber 32.
In
During the step of transporting dry powder into the interior mixing chamber 32, the collar of the sealable opening 52 may become filled and possibly impacted by dry powder which could interfere with the step of injecting a process compatible solution through the sealable opening arising from dry powder clogging the opening. This problem can be overcome by first tying off the collar from the exterior with a tying member 80 illustrated by dashed circle, e.g. rope, to collapse or restrict the collar of the sealable opening 52 to prevent the dry powder form becoming impacted in the collar. At the time of injecting a process compatible solution into the mixing bag 30, the tying member 80 is removed.
In the pictorial representation of
The computer system 92 can control the operation of: (i) the pump 106 through a control line shown by dashed line 138; (ii) the control valve 122 through a control line shown by dashed line 132; (iii) clamp 110 through a control line shown by dashed line 134; and (iv) clamp 112 through a control line shown by dashed line 136. In addition, the filter 108 can be operated under computer control through a control line shown by dashed line 142. The sensor 130, which may monitor the concentration or solution density, can be operated under computer control through a control line shown by dashed line 146.
The term “computer” and “computer system” is intended to include all ancillary components such as, without limitation, network servers, storage devices including rotating disk memory storage systems, modems, communication lines, digital subscriber lines (“DSL”), keyboards and the like.
The pictorial representation of
The pictorial representation of
When the selected volume of process compatible solution is injected into the interior mixing chamber, the step of enabling agitation of the powder and process compatible solution in the interior mixing chamber 32 is commenced to form a solution having powder in suspension with a selected concentration. Clamp 110 is opened to permit passage of solution under pump pressure to pass through filter 108. Clamp 112 is closed to direct the solution through the inlet 150 of filter 108, through the filter 108 and out of the outlet 152. The solution flow is from the interior mixing chamber 32, out of opening 52, through the second conduit system 102, through the inlet 150, filter 108 and outlet 152, through the first conduit system 100, through opening 50 back into the interior mixing chamber 32.
When a determination is made that the solution comprising the dry powder in suspension in the process compatible solution is at a selected concentration or at a selected density, the step of withdrawal is illustrated in
In addition,
The second conduit system 102 has a distal end 170 terminating in an insertion sleeve 174 which removeably couples to extension 176 of opening 52. The distal end 170 may be a flexible section to facilitate easy coupling of insertion sleeve 174 with extension 176 of opening 52.
In
In the pictorial representation of
The word “agitation” as used herein is used in its broadest sense and is intended to include all known apparatus and systems for mixing powder and fluids or liquids to form a solution including, without limitation, pumps, magnetic mixing apparatus, mechanical vibration apparatus, mechanical mixing apparatus wherein a mixing apparatus may be inserted through a opening to mix the solution, mechanical mixing apparatus having impellers driven by a shaft and motor or the like.
The solution may be in the form of a filter aid which can be used in a dynamic filtering application as described hereinbefore.
In the embodiment represented by
The mixing bag 700 has an interior mixing chamber 702 has a volume sufficient to receive a predetermined weight of dry material capable of being forming and remaining in suspension in a process compatible solution and a selected volume of process compatible solution to form a solution having the material in suspension with a selected concentration. A sealable opening 704 is provided for separately filling the mixing bag 700 with a dry powder at a remote location as described in
The preformed mixing bag 700 has a substantially rectangular shape and has three sealable opening, 704, 706 and 708. Opening 704 is dedicated as a filling port openings 706 and 708 function as the at least two sealable openings as described hereinbefore.
Appropriately sized peristaltic pumps depicted by elements 722, 724 and 726 are provided to perform the functions of injecting a process compatible solution into the interior mixing chamber 702 of mixing bag 700, agitating the solution and withdrawing the solution when a selected concentration is achieved.
Line 730 extends from opening 708 to pump 720. Line 734 extends from opening 706 and is bifurcated to extend through a clamp 744 to pump 722 and to branch line 740 to clamp 748. Line 752 extends from clamp 748 to line 760 which extends between pump 720 and clamp 766. Line 770 extends between a source of feedstock or process compatible solution 772. Line 774 is connected to line 770 and extends to a clamp 776 located at the inlet of pump 724. Line 800 extends from pump 724 to line 802. Line 802 connects pump 722 to a filter 804 to perform the dynamic filtering of a designated fluid to be filtered.
In operation, the mixing bag having the dry powder is placed into position and the apparatus is connected as described. The mixing bag may contain 5 kg of Celpure® media which is to be used for the delivery of 5 kg of Celpure® media to a filtration process. The mixing bag holds up to 50L of suspension or solution which will produce a Celpure® body feed concentration of 100 g/L. The suspension may be produced with a process compatible solution, e.g., water, or feedstock,. e.g. whole yeast cells, mammalian cells and Lysed E. Coli cells.
Depending on the required body feed rate, the solution at a selected concentrated may be pumped, either undiluted at 100 g/L, into the filter 804 or diluted with feedstock, via an inline mixer pump 724, to a lower target concentration, e.g. 2 g/L.
The mixing bag 700 is injected or filled with a process compatible fluid from source 772 using pump 720. Clamp 776 is closed to occlude line 774 and clamp 766 is opened providing the pump 720 with access to the source 772 through line 760, opened clamp 766 and line 770. The volume of process compatible solution would be about 48L. The pump 720 fills the mixing bag at about 20 L/min.
Upon completion of the injecting of the process compatible solution into the mixing bag 700, the agitation step is then initiated. This is accomplished by closing clamp 766, opening clamp 748 and reversing flow of pump 720 at a flow rate of about 20 L/min. The agitation time period is about 10 minutes to obtain the selected concentration of 100 g/L.
Upon completion of the step of agitating the solution, the solution is ready to be withdrawn. The withdrawal is accomplished by opening clamp 744 to withdraw the solution at the selected concentration from line 740 using pump 722 through line 802 to the filter 804.
If it is desired to reduce the higher concentration to a lower target concentration using a feed stock form source 772, the following steps may be taken. Clamp 766 is occluded or closed and clamp 776 is open to enable pump 724 to controllably dilute the solution with the feed stock at an appropriate feed rate to obtain the desired lower target concentration.
Depending on the structure of the mixing bag, the mixing bag can be recycled for subsequent cycle, or if the mixing bag is a single use mixing bag, the mixing bag is then discarded.
The teachings of this invention include use of the mixing bag in a system. The system comprises a mixing bag having an interior mixing chamber having a volume sufficient to receive a predetermined weight of dry powder and a selected volume of process compatible solution to form a solution having powder in suspension with a selected concentration and wherein the interior mixing chamber has a predetermined weight of dry powder stored therein. The interior-mixing chamber having a first end and a second end wherein the second end is located in an opposed spaced relationship to the first end. The mixing bag includes at least two sealable openings wherein one of the at least two sealable openings extends from a location exterior to mixing bag and into communication with interior mixing chamber at the first end and which is configured for at least one of enabling transporting dry powder into the interior mixing chamber, enabling agitation of powder and process compatible solution in interior mixing chamber to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber.
The other of the at least two opening extends from a location exterior to the mixing bag and into communication with the interior mixing chamber at the second end which is configured for at least one of enabling injecting a process compatible solution into the interior mixing chamber to form a solution having powder in suspension, enabling agitation of powder and process compatible solution in the interior mixing chamber to form a solution having powder in suspension with a selected concentration and enabling withdrawal of the solution with a selected concentration from the interior mixing chamber.
The system includes a first conduit system 100 configured to be operatively removeably connected to the one of the at least two sealable openings for enabling agitating of the solution of powder and process compatible solution in the interior mixing chamber to form a solution of the process compatible solution having the powder in suspension with a selected concentration. A second conduit system 102 is operatively removeably connected to the other of the at least two sealable openings and to the first conduit system for enabling injection of a process compatible solution into the interior mixing chamber through the other of the at least two openings to form a solution having powder in suspension, for enabling agitation of the powder and process compatible solution within the interior mixing chamber through the at least two openings to form a solution having powder in suspension with a concentration and for enabling withdrawal of solution from the interior mixing chamber with a selected concentration through the other of the at least two openings.
A pump 106 shown in
Withdrawal of the solution at the selected concentration may be performed using at least one of the first conduit system and the second conduit system as discussed hereinbefore.
The system may further comprise a controller for controlling the pump to inject a selected volume of make-up process compatible solution from a source of process compatible solution into the interior mixing chamber.
The following are examples are based on use of a preformed mixing bag having an interior mixing chamber having a volume sufficient to receive a predetermined weight of dry powder and a selected volume of process compatible solution to form a solution having powder in suspension with a selected concentration using the teaching of the present invention.
In certain of the Examples set forth below, the Examples include use of Celepure P65® media, Celepure 300® media and Celepure 1000® media. The specifications of the above Celpure® media are set forth below for reference.
Celepure P65® media is characterized as a Lightly Calcined, Purified Siliceous Earth, the specifications of which are as follows:
Celepure P100® media is characterized as a Calcined, Purified Siliceous Earth, the specifications of which are as follows:
Celepure P300® media is characterized as a Lightly Calcined, Purified Siliceous Earth, the specifications of which are as follows:
Celepure P1000® media is characterized as a Lightly Calcined, Purified Siliceous Earth, the specifications of which are as follows:
The following example utilizes Celepure 100® media.
A preformed mixing bag having a structure illustrated in
Five kilograms (5 kg) of Celepure 100® media was then transported into the mixing bag through the third sealable opening in the form of a sealing port shown in
The solution was prepared using the five kilograms (5 kg) of Celepure P100® media stored in the mixing bag. The tying member affixed to the collar of the second sealable opening was removed. The second sealable opening and third sealable opening were unsealed. The first conduit system and the second conduit system were then operatively attached the first sealable opening and the second sealable opening, respectively. The make-up process compatible solution was injected through the second sealable opening. The total selected volume of process compatible solution injected into the interior mixing chamber was about 13 gallons (about 48 liters). The injection rate was about 5.3 gallons per minute (about 20 L/minute). Upon injection of the selected volume of liquid into the interior mixing chamber, a peristaltic pump was used to provide the desired agitation through the second and third sealable openings. The reversible pump agitation was at the rate of about 3 gallons per minute (about 10 L/minute) with size 0.75 inch ID tubing. The filter was a standard process compatible solution filter to remove impurities and had a through put capability equal to the pump flow rate.
The-time period for agitation was about ten (10) minutes.
In this example, the solution was agitated to form a solution having dry powder in suspension with a selected concentration of 100 g/L.
The solution was then withdrawn and used as a filter aid as discussed in connection with
Table B below set forth Examples 2, 3 and 4 using the mixing bag of the present invention and the system and apparatus described in
Table C below set forth Examples 5, 6, 7 and 8 using the mixing bag of the present invention and the system and apparatus described in
Packaging configurations for the mixing bag of the present invention and materials filled therein for practicing this invention come in a variety of sizes for non-bulk options. The preformed mixing bag can be fabricated to be a round shape, square shape, rectangular shape, oblong shape, conical shape, elliptical shape, triangular shaped or other geometrical shape. The bottom of the mixing bag can be fabricated to be sloped, conical shaped, flat or other appropriate shape to support the dry powder in the mixing bag.
The mixing bag, when placed into a shipping container, assumes the shape of the container. As discussed above with reference to
Such non-bulk options include mixing bags formed of plastic materials, poly materials, HyClone films, e.g. HyQ CX5 Film, or other appropriate chemically and physically compatible materials, as is well known to persons skilled in the art. For Example, in pharmaceutical applications, the weights of dry powder could be in the 5 kg to 15 kg range of weights of dry powder using a mixing bag formed of poly materials and the weights of dry powder weights in the range of 10 kg to 22.5 kg range of weights of dry powder using a mixing bag formed of HyClone films, e.g. 3-web Film, HYQM1 and HYQBX6 (Attane 4203), a single web film, HyQCX5-9, Formulation PL2403 and a single web Film, HyQCX5-14, Formulation PL2438-1.
Sterile Fluid handling bags for medical applications and mixing bags for industrial and other applications as discussed above are typically constructed of multi-layer film(s). The following are typical materials utilized in the manufacture of multi-layer films suitable for use in mixing bags of the present invention and are shown in Table D:
The following are examples of multi-layer bags that can be fabricated from the above materials and are shown in Table E:
The mixing bags of the present invention may comprise single layer film or multi-layer films depending on the application and engineering requirements for the bag. The materials used for fabricating the mixing bag can be selected to maximize performance of the mixing bag.
Typically, the mixing bags of the present invention are designed for single use applications. An Article entitled Quantitative Economic Evaluation of Single Use Disposables in BioProcess, comprising nine (9) pages, which appeared in the May/June, 2002 issue of Pharmaceutical Engineering, compares single use technology and traditional steel vessels used in biomanufacturing as well as an introduction to the concept of disposable bag technology.
By utilizing the teachings of the present invention, there are three (3) important dry powder material, referred to as the product, aspects which remain substantially constant in the solution and during the process of forming the solution. The three (3) important important dry powder material product aspects are as follows: (i) the solution maintains substantially the same product density when used in an application, e.g., as a filter cake when the solution is used as a filter aid; (ii) the permeability of the product in solution remains substantially unchanged; and (iii) the integrity of the product in solution remains substantially the same, e.g., the structure of the material product does not substantially decompose or break down into smaller particles during formation of the solution.
One attribute of forming a solution using a selected dry material using the teachings of the present invention, is that the process of forming the solution, including agitation thereof, does not significantly degrade the critical physical characteristics of the dry powder material product which is essential in an application using the solution which relies on the critical physical characteristics of the material product in solution remaining substantially unchanged to perform a desired function.
In one application, the dry material used may be a Celpure® Diatomite that is to be used as a filter aid. In such application, the fundamental intricate, fine particulate, and porous structure of the diatom frustule forming the Celpure® Diatomite gives diatomite its low density, high surface area, high porosity and permeability. These attributes give diatomite its unique commercial value and versatility unmatched by other natural forms of silica for certain applications, e.g. in filtration applications. Moreover diatomite may be processed to impart a specific permeability range which is of general importance in solids-liquids separation applications.
In the field of filtration, many methods of particle separation from fluids employ diatomite products as filter aids. The intricate and porous structure unique to diatomite silica is particularly effective for the physical entrapment of particles in filtration processes. It is common practice to employ diatomite products when improving the clarity of fluids that contain suspended particles or particulate matter, or have turbidity.
For use in filtration, diatomite products are usually processed to provide a range of filtration rates, which are closely related to their permeability. Permeability is reported in units of Darcies, as discussed hereinbefore, and is commonly abbreviated “Da”. The permeability, in Da, is readily determined (European Brewery Convention, 1987) using a specially constructed device designed to form a filter cake on a septum from a suspension of diatomite in water, and then measuring the time required for a specified volume of water to flow through a measured thickness of filter cake of known cross-sectional area. The principles have been previously derived for porous media from Darcy's law (Bear, 1972), so an array of alternative devices and methods are in existence that correlate well with permeability. Diatomite filter aids that are currently commercially available span a wide range of permeability, from about 0.001 Da to about 30 Da. The selection of a filter aid with a particular permeability suitable for a specific filtration process depends on the flow rate and degree of fluid clarification desired for the particular application. As such, using a dry powder with a known or selected permeability which remains substantially unchanged during preparation of the solution using the dry powder in accordance with the teachings of this invention is one of the desired attributes of this invention.
In another application, the dry material used may be LRA®, Celpure®, and Chromosorb® designed to be used as Sorbents and Chromatography Media. In such application, a sorbent's usefulness is in removing soluble constituents from biologic and non-biologic solutions and the desired criteria for using the same can be traced to its surface area, density, or other physical attributes that effect the mass transfer of solutes in solution.
As such, using a dry powder with known or selected physical attributes that effect the mass transfer of solutes in solution and a dry powder with known or selected physical attributes which remain substantially unchanged during preparation of the solution using the dry powder in accordance with the teachings of this invention is one of the desired attributes of this invention.
It is envisioned that the mixing bag interior mixing chamber has a volume sufficient to receive a predetermined weight of dry material capable of being forming and remaining in suspension in a process compatible solution and a selected volume of process compatible solution to form a solution, suspension or slurry having the material in suspension with a selected concentration or select density or a density within a range of selected densities. Such a mixing bag has utility for a variety of applications. The dry material can be a granulated or powder concentrate capable of forming a solution. It is preferable that the powder be as dry as possible. However, the teachings of the present invention can be used with a slightly hydrated media. A more wet or the heavier hydrated media makes it more difficult it becomes to break up the particles to form the desired solution, suspension or slurry. Injecting of the process compatible solution from the bottom of the mixing bag enhances the formation of the desired solution, suspension or slurry, particularly with a dry medium or a slightly hydrated media.
The mixing bag can be used in the industrial field for producing solutions used in making filter aids; in the agriculture field for fertilizers, pesticides, gypsum; in the medical field for kidney dialysis and in the food and beverage industry for making solutions from dry powder for use as beverages or the like. For example, U.S. Pat. No. 5,121,857 discloses agitating apparatus for dispensing fruit juices from a bag in a box arrangement wherein the a metalized plastics material flexible bag containing a fruit-drink having fruit particles suspended therein. The mixing bag of the present invention can be used with such agitating and dispensing apparatus in the beverage industry.
In the preferred embodiment, the dry powder is a non-soluble powder. In the preferred use of the teachings of the present invention, the non-soluble powder maybe be selected from a group consisting of diatomaceous earth, Celepure P65® media, Celepure P100® media, Celepure 300® media, Celepure P1000® media, LRA® media and sorbents.
In another embodiment, the dry powder may be a Sorbent. A Sorbent is associated with Sorption. Sorption is the association of a gas phase or aqueous substance with a solid material, known as the sorbent, by surface attachment (adsorption) or dissolution and migration into the solid phase (absorption). “Solid phase” refers to material that behaves as a solid according to macroscale measures. At a chemical level, the surface of that solid may act more like an oil film. “Adsorption” refers to association of a sorbate with surfaces. “Absorption” implies penetration of a sorbate into the sorbent, by diffusion.
In yet another embodiment, the dry powder can be used for Chromatography. By classical definition, chromatography is a separation process that is achieved by distributing the substances to be separated between a mobile phase and a stationary phase. Those substances distributed preferentially in the moving phase pass through the chromatographic system faster than those that are distributed preferentially in the stationary phase. As a consequence, the substances are eluted from the column inverse order of their distribution coefficients with respect to the stationary phase. In this definition LRA®, Celpure®, and Chromosorb® can all be called chromatography media, sorbents, or filter aids.
LRA® is not a diatomite, however it is a silicate. Chromosorb products are a mix. Some are solely diatomite, some are diatomite coated with polymers (e.g. Teflon) and some are pure polymers.
Celpure is 100% diatomite
The teachings of the present invention has utility for the hydrating of chromatography media in a mixing bag and the withdrawal of and loading of chromatography media at a concentrated solution from the mixing bag into chromatography media columns in the same manner as a Celepure® media is used as a filter aid as described herein.
It is also envisioned that if a significant volume of dry powder is to be simultaneously processed with a process compatible solution to form a solution, suspension or slurry having a selected concentration, that a plurality of mixing bags could be concurrently injected with a process compatible solution, agitated using an agitation process, apparatus or system disclosed herein and the resulting solution at selected concentration can then be withdrawn either sequentially or in parallel from the plurality of mixing bags.
It will be appreciated that various alterations and modifications may be made to the mixing bag, methods, apparatus and system using the teachings of the present invention. All such variations and modifications should be considered to fall within the scope of the invention as broadly hereinbefore described and as claimed hereafter.
All such uses, variations, modifications and the like are anticipated to be within the scope of this invention.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10454173 | Jun 2003 | US |
| Child | 11288178 | Nov 2005 | US |
